GI Dynamics
Morphic Medical is dedicated to developing innovative, minimally invasive therapies for type 2 diabetes and obesity. Their flagship product, RESET, is an endoscopically delivered device therapy designed to target the underlying causes of these metabolic diseases. The company aims to bridge the gap between pharmaceuticals and surgery, providing patients with effective treatment options that improve health outcomes and quality of life.
Industries
Nr. of Employees
medium (51-250)
GI Dynamics
320 Congress Street, 3rd Floor, Boston, MA 02210
Products
Investigational endoscopically delivered intestinal liner (temporary duodenal-jejunal bypass liner)
A minimally invasive, endoscopically implanted temporary liner placed in the proximal small intestine to reduce nutrient contact with proximal bowel and modify metabolic outcomes; used in clinical studies to assess effects on glycemic control and body weight.
Investigational endoscopically delivered intestinal liner (temporary duodenal-jejunal bypass liner)
A minimally invasive, endoscopically implanted temporary liner placed in the proximal small intestine to reduce nutrient contact with proximal bowel and modify metabolic outcomes; used in clinical studies to assess effects on glycemic control and body weight.
Services
Management and delivery of multi-center clinical trials including protocol development, site selection, enrollment, monitoring, safety oversight and scheduled follow-up for investigational endoscopically delivered intestinal liner therapies.
Collection, curation and analysis of registry data from treated patients to support safety surveillance, effectiveness assessments and scientific publications.
Consultative support for regulatory strategy, submission preparation (IDE/IDE-equivalent), and implementation or maintenance of QMS to support clinical commercialization.
Access to external clinical experts in endocrinology, metabolic surgery, gastroenterology and nephrology to provide input on trial design, clinical endpoints and translational research.
Management and delivery of multi-center clinical trials including protocol development, site selection, enrollment, monitoring, safety oversight and scheduled follow-up for investigational endoscopically delivered intestinal liner therapies.
Collection, curation and analysis of registry data from treated patients to support safety surveillance, effectiveness assessments and scientific publications.
Consultative support for regulatory strategy, submission preparation (IDE/IDE-equivalent), and implementation or maintenance of QMS to support clinical commercialization.
Access to external clinical experts in endocrinology, metabolic surgery, gastroenterology and nephrology to provide input on trial design, clinical endpoints and translational research.
Expertise Areas
- Clinical trial management and execution
- Endoscopic gastrointestinal device therapy development
- Regulatory affairs and medical device quality systems
- Clinical registry operations and real-world evidence generation
Key Technologies
- Endoscopic implantation of temporary intestinal liners
- Duodenal-jejunal bypass liner therapy concepts
- Randomized sham-controlled clinical trial methodology
- Investigational device regulatory pathways (IDE-type)
News & Updates
GI Dynamics announced that Timothy Barberich resigned from the Board and was replaced by Praveen Tyle, Ph.D. as a new director, with additional committee appointments.
GI Dynamics announced the initial closing of its Series A financing, raising $10 million led by Crystal Amber, with plans to support clinical trials and regulatory milestones.
Updated positive data from the ABCD Worldwide EndoBarrier Registry shows improvements in weight, glycemic control, blood pressure, and cholesterol in patients treated with EndoBarrier.
Results from a multicenter study showed that the EndoBarrier System met efficacy and safety endpoints, demonstrating potential as a treatment for type 2 diabetes and obesity.
The first patient was enrolled in the India I-STEP trial, a pivotal study evaluating the safety and efficacy of EndoBarrier for glycemic improvement in patients with uncontrolled type 2 diabetes and obesity.
Updated positive data from the ABCD Worldwide EndoBarrier Registry shows improvements in weight, glycemic control, blood pressure, and cholesterol in patients treated with EndoBarrier.
GI Dynamics announced that Timothy Barberich resigned from the Board and was replaced by Praveen Tyle, Ph.D. as a new director, with additional committee appointments.
GI Dynamics announced the initial closing of its Series A financing, raising $10 million led by Crystal Amber, with plans to support clinical trials and regulatory milestones.
Updated positive data from the ABCD Worldwide EndoBarrier Registry shows improvements in weight, glycemic control, blood pressure, and cholesterol in patients treated with EndoBarrier.
Results from a multicenter study showed that the EndoBarrier System met efficacy and safety endpoints, demonstrating potential as a treatment for type 2 diabetes and obesity.
The first patient was enrolled in the India I-STEP trial, a pivotal study evaluating the safety and efficacy of EndoBarrier for glycemic improvement in patients with uncontrolled type 2 diabetes and obesity.
Updated positive data from the ABCD Worldwide EndoBarrier Registry shows improvements in weight, glycemic control, blood pressure, and cholesterol in patients treated with EndoBarrier.